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Perineural Low-dose Dexamethasone Added to Infraclavicular Block Anesthesia

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 3
Locations
Romania
Study Type
Interventional
Intervention
Dexamethasone
Ropivacaine
Paracetamol
Morphine
Lidocaine
Sponsored by
Foisor Orthopedics Clinical Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I-III,
  • BMI<40,
  • non-anemic

Exclusion Criteria:

  • High risk grade hypertension, chronic renal failure, known allergy to local anesthetic or NSAIDs, chronic treatment with steroids, drugs dependency, history of diabetes mellitus, ulcer or chronic gastritis, infection on the puncture site, chronic obstructive pulmonary disease, neuropathy at the surgical level

Sites / Locations

  • Foisor Orthopedic Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+1 ml saline=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.

VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+2 mg dexamethasone=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.

VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+4 mg dexamethasone=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.

Outcomes

Primary Outcome Measures

Sensory block duration
The time in minutes measured between VIB block to first analgetic request

Secondary Outcome Measures

Motor block duration
The time in minutes measured between VIB block to complete movement of the hand
Glycemic variations at 4 hours post-VIB block
Determination of blood sugar level
Number of patients opioid free analgesia
Number of reported patients with no need opioid analgesia
VAS at the block regression
VAS evaluation on the VAS scale (0 - no pain, 10 - the worst pain possible )
Cutaneous temperature ice-probe
The cold sensation on ice-probe test to both arms could be the same or burn likely
Total morphine consumption at 24 hours
Cumulative morphine administration in milligrams

Full Information

First Posted
February 19, 2016
Last Updated
August 19, 2020
Sponsor
Foisor Orthopedics Clinical Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02698995
Brief Title
Perineural Low-dose Dexamethasone Added to Infraclavicular Block Anesthesia
Official Title
Analgetic Efficiency of Single-shot Perineural Low Dose Dexamethasone Added to Infraclavicular Block Anesthesia for Upper Limb Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Foisor Orthopedics Clinical Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dexamethasone has an evidence-based indication in postoperative emesis prophylaxy and as a antiinflammatory steroid. Although the perineural administration is off-label, several studies recognised its analgetic action as an adjuvant for peripheral nerves blockade, permitting to reduce the concentration of the local anesthetics and extending the sensory and motor block.Questions remain concerning the mechanism of action, optimal dose, the lack/degree of toxicity and the comparison with intravenous administration.The aim of this prospective randomized controlled study is to investigate the efficacy of analgesia with 4 mg or 2 mg Dexamethasone added to a combination of ropivacaine 0,5% and lidocaine 1% in vertical infraclavicular blockade (VIB) anesthesia for upper limb surgery.
Detailed Description
The investigators conducted a prospective randomized controlled study in 150 patients American Society of Anesthesiologists (ASA) score I-III scheduled for upper limb surgery , divided in 3 groups: group A received anesthesia VIB block with ropivacaine 0,5% 100 mg +lidocaine 1%+1 ml saline; group B received VIB block with ropivacaine 0,5% 100 mg +lidocaine 1% + 2 mg dexamethasone; group C received ropivacaine 0,5% 100 mg +lidocaine 1% + 4 mg dexamethasone.The anesthesiologist may use the ultrasound for visual guidance, but should also use the nerve stimulator in order to maintain the homogeneity of the procedure. Intraoperative sedation was provided with intermittent bolus 10-20 mg IV Propofol. Postoperatively all patients received the same analgetic protocol when Visual Analog Pain Scale (VAS) over 3 with IV Perfalgan and Lornoxicam 8 mg/12 hours for 24 hours. If after 30 minutes VAS is still over 3, a loading dose of morphine 0,05 mg/kg should be administered. At first analgetic request, the nurse conducts an ice-probe test to both arms and will note the answer: same cold, slightly burn, burn, aching with the reason to test the potentially hyperalgesia effect related to ropivacaine. The data recorded are: time to first analgetic use, VAS at block regression, ice-probe test, motor and sensitive block duration, glycemic variations at 4 h, neurological complications immediately after block, total morphine consumption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Placebo Comparator
Arm Description
VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+1 ml saline=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+2 mg dexamethasone=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+4 mg dexamethasone=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Perfalgan
Intervention Description
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Morphine Sulfate ER
Intervention Description
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Xylocaine
Intervention Description
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Primary Outcome Measure Information:
Title
Sensory block duration
Description
The time in minutes measured between VIB block to first analgetic request
Time Frame
First 24 hours
Secondary Outcome Measure Information:
Title
Motor block duration
Description
The time in minutes measured between VIB block to complete movement of the hand
Time Frame
First 24 hours postoperatively
Title
Glycemic variations at 4 hours post-VIB block
Description
Determination of blood sugar level
Time Frame
First 4 hours postoperatively
Title
Number of patients opioid free analgesia
Description
Number of reported patients with no need opioid analgesia
Time Frame
First 24 hours postoperatively
Title
VAS at the block regression
Description
VAS evaluation on the VAS scale (0 - no pain, 10 - the worst pain possible )
Time Frame
First 24 hours postoperatively
Title
Cutaneous temperature ice-probe
Description
The cold sensation on ice-probe test to both arms could be the same or burn likely
Time Frame
First 24 hours postoperatively
Title
Total morphine consumption at 24 hours
Description
Cumulative morphine administration in milligrams
Time Frame
First 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-III, BMI<40, non-anemic Exclusion Criteria: High risk grade hypertension, chronic renal failure, known allergy to local anesthetic or NSAIDs, chronic treatment with steroids, drugs dependency, history of diabetes mellitus, ulcer or chronic gastritis, infection on the puncture site, chronic obstructive pulmonary disease, neuropathy at the surgical level
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioan Cristian Stoica, MD Prof
Organizational Affiliation
Foisor Orthopedics Clinical Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Foisor Orthopedic Clinical Hospital
City
Bucharest
ZIP/Postal Code
021383
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
3376761
Citation
Kalichman MW, Powell HC, Myers RR. Pathology of local anesthetic-induced nerve injury. Acta Neuropathol. 1988;75(6):583-9. doi: 10.1007/BF00686203.
Results Reference
result
PubMed Identifier
3942334
Citation
Myers RR, Kalichman MW, Reisner LS, Powell HC. Neurotoxicity of local anesthetics: altered perineurial permeability, edema, and nerve fiber injury. Anesthesiology. 1986 Jan;64(1):29-35.
Results Reference
result
PubMed Identifier
18784493
Citation
Zink W, Graf BM. The toxicity of local anesthetics: the place of ropivacaine and levobupivacaine. Curr Opin Anaesthesiol. 2008 Oct;21(5):645-50. doi: 10.1097/ACO.0b013e32830c214c.
Results Reference
result
PubMed Identifier
21519308
Citation
Williams BA, Hough KA, Tsui BY, Ibinson JW, Gold MS, Gebhart GF. Neurotoxicity of adjuvants used in perineural anesthesia and analgesia in comparison with ropivacaine. Reg Anesth Pain Med. 2011 May-Jun;36(3):225-30. doi: 10.1097/AAP.0b013e3182176f70.
Results Reference
result
PubMed Identifier
25774458
Citation
Huynh TM, Marret E, Bonnet F. Combination of dexamethasone and local anaesthetic solution in peripheral nerve blocks: A meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2015 Nov;32(11):751-8. doi: 10.1097/EJA.0000000000000248.
Results Reference
result
PubMed Identifier
24817819
Citation
Kawanishi R, Yamamoto K, Tobetto Y, Nomura K, Kato M, Go R, Tsutsumi YM, Tanaka K, Takeda Y. Perineural but not systemic low-dose dexamethasone prolongs the duration of interscalene block with ropivacaine: a prospective randomized trial. Local Reg Anesth. 2014 Apr 5;7:5-9. doi: 10.2147/LRA.S59158. eCollection 2014.
Results Reference
result

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Perineural Low-dose Dexamethasone Added to Infraclavicular Block Anesthesia

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